As artificial intelligence (AI), machine learning (ML) and other digital tools gain prominence across industries, their application in cell and gene therapy (CGT) has become a topic of increasing interest. Discussions at recent meetings of the International Society of Cell and Gene Therapy (ISCT), including the 2024 ISCT Commercialisation Signature Series (CSS), highlight the potential of these tools to help optimise CGTs.
Through real-world case studies, including applications in smart bioprocessing and advanced analytics, this paper, co-authored by the CGT Catapult, examines how these technologies can enhance manufacturing efficiency and increase market access. It also provides guidance definitions for the evolving automation and digitalisation activities in CGT, emphasizing the importance of standardised language to facilitate progress in the field.
